Author: asingh

CAMBRIDGE, Mass. and REDWOOD CITY, Calif., March 13, 2018 – Foundation Medicine, Inc. (NASDAQ:FMI) and Guardant Health, Inc. announced an agreement to settle false advertising challenges that the companies had filed against each other under the Lanham Act related to advertising for their respective liquid genomic profiling assays. Under the terms of the settlement, the lawsuit and counterclaims will be dismissed with prejudice. The companies also agreed to create a rapid-resolution process in the event of further advertising-related disputes.

In conjunction with the settlement, the parties further agreed to establish a working group to explore the development of standard formulas and definitions for the validation of genomic profiling assays.

Guardant Health’s CEO, Helmy Eltoukhy stated, “We are pleased to resolve this legal matter in away that not only addresses our respective concerns about historical marketing practices but focuses on educating clinicians and improving patient care.”

Foundation Medicine’s CEO, Troy Cox, stated, “We’re pleased with this settlement that enables both companies to focus on the needs of the oncology community.”

About Guardant Health

Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $500 million from leading investors. Its first product, the Guardant360 assay, came to market in 2014, and is now widely ordered and commercially available in more than 30 countries. In 2016, it announced Project LUNAR, an effort to apply Guardant Health’s technology platform to early detection, recurrence monitoring, and assessing minimal residual disease. Guardant Health and Guardant360 are registered trademarks of Guardant Health, Inc. Learn more at www.guardanthealth.com.

About Foundation Medicine

Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

REDWOOD CITY, Calif. – March 21, 2017 — New findings from researchers at Massachusetts General Hospital Cancer Center and Harvard Medical School demonstrate the ability of the Guardant360® assay, the most-widely ordered comprehensive liquid biopsy, to overcome challenges that intra- and inter-tumor heterogeneity present to treating patients with advanced cancer.

The research, which was published this month in Cancer Discovery, described the effects of an investigational drug that inhibits the activity of FGFR2 mutations in cholangiocarcinoma. Researchers also examined the ability of Guardant360 to characterize new resistance alterations that arose in response to the treatment.

The results suggest that the inclusion of a comprehensive liquid biopsy may be the optimal method for identifying resistance alterations in patients with advanced cholangiocarcinoma, as it can provide a summary of the mutations occurring across the patient’s entire disease burden.

“As the sensitivity of circulating DNA sequencing increases, this may become the primary method through which the genomic evolution of tumors is evaluated,” an editorial published in the same March 2017 issue of Cancer Discovery noted. “The limitations imposed by the spatial boundaries of biopsies may needlessly limit our capacity to fully comprehend the complexity of heterogeneous tumors.”

While the prognosis for patients with advanced cholangiocarcinoma is poor, with median survival of less than one year, a new class of drugs is showing promise for treating the up to 20 percent of cholangiocarcinoma cancers that harbor FGFR2 fusions. In this phase 2 trial of BGJ398, an FGFR2 inhibitor, patients demonstrated a significantly improved objective response rate of 22% and a median time on treatment of 188 days.

As is the case with many targeted drugs, the cancer eventually developed resistance to the treatment, and the disease progressed. At the time of progression, researchers collected blood samples from a sub-group of trial subjects for Guardant360 testing and identified several novel resistance alterations, along with one well-known gatekeeper alteration, all in the FGFR2 gene.

Single lesion tissue biopsies performed at disease progression from the same patients contained only a fraction of the alterations detected by Guardant360, researchers reported. Additionally, in a rapid autopsy performed after one of the patients in the study died, twelve additional tissue biopsies from multiple metastatic lesions identified several more mutations missed in the original tissue biopsies but detected by Guardant360. Importantly, those resistance mutations were absent from lesions that had been shown, by CT scan, to be responding to the trial drug.

“These findings are further evidence of the potential of ctDNA to provide a more global summary of the genomic alterations present in advanced cancers. Here, a tissue biopsy failed to capture the full picture of tumor heterogeneity and missed important resistance alterations. This is significant in diseases where acquired resistance can inform treatment decisions, especially in cholangiocarcinoma, as next-generation FGFR2 inhibitors are already in clinical trials,” said Dr. Richard Lanman, Guardant Health’s Chief Medical Officer.

About Guardant Health
Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $200 million from leading venture capital firms. Its first product, the Guardant360 assay, came to market in 2014, and is now the most widely ordered comprehensive liquid biopsy commercially available. In 2016, it announced Project LUNAR, an effort to apply Guardant Health’s technology platform to early detection, recurrence monitoring, and assessing minimal residual disease. Guardant Health and Guardant360 are registered trademarks of Guardant Health, Inc.

Traditionally, oncologists believed that solid-cancer tumors were largely homogeneous – that their molecular makeup was the same throughout the body—and treated their patients accordingly.

We now know that tumors are far more complex. Not only are they densely heterogeneous1, and vary significantly both within and between primary and metastatic sites, they also change over time in response to treatment2.

Spatial Heterogeneity
A tumor biopsy captures, by necessity, only a small piece of a tumor to be used for histological staining or genomic sequencing. As a result, important disease features may not be present in the specific section sampled by the biopsy needle. This intra-tumor spatial heterogeneity can present real challenges to patients with advanced cancer and to the doctors who are building their treatment plans. If a biopsy needle misses the section of the tumor containing an important drug target, no genomic testing performed on that tissue sample, however robust, will be able to find it.

A landmark paper published in the New England Journal of Medicine (NEJM) in 2012 demonstrated the extent of this complexity. Researchers performed DNA sequencing on nine different biopsies taken from a single tumor and found that each contained an average of 70 somatic genomic alterations – but just 34 percent of those alterations were present in every region.

The diagnostic challenge presented by heterogeneity is amplified when tumors begin to spread and metastasize. Metastatic lesions are often in sites that are difficult or impossible to biopsy such as in the bones or brain, or are present in such numbers as to preclude thorough sampling. It’s usually impractical – and very painful/dangerous for the patient – to perform biopsies on multiple sites. However, these lesions can contain different cellular characteristics, including potentially druggable genomic targets that differ from the primary tumor site. Indeed, in the NEJM study above, the low inter-biopsy concordance in the primary tumor was even lower in the metastases. And these genomic differences matter. In another, more recent study, 53% of patients harbored clinically informative alterations in one or more metastases that were not present in the primary tumor.

In contrast to tissue-based tests, which necessarily sample only a small portion of a single tumor, liquid biopsies sample cell-free DNA shed from tumor cells throughout the body, thus providing the doctor a global summary of the genomic alterations present in the patient. Importantly, the fastest-growing cells, which shed the most cell-free DNA, are the most clinically relevant because metastases and fast-growing tumors are more likely to pose a threat to the patient’s life than a slow-growing primary tumor3.

Temporal Heterogeneity
The genomics of a tumor may vary not only in space, but also over time.

For instance, in non-small cell lung cancer about 15-40 percent of patients’ tumors harbor an alteration in the EGFR gene. Tumors with these alterations can be effectively treated with drugs like erlotinib, gefitinib, and afatinib; however, eventually the tumors evolve, and typically acquire new alterations that subvert the efficacy of the original tyrosine kinase inhibitor. In this specific example, the most common of these acquired resistance alterations is EGFR T790M, in turn, can be targeted by new therapies designed to specifically inhibit tumors with this resistance mutation.

And in multiple studies, researchers have shown that when there is a long delay between the time a tissue sample is acquired and when the liquid biopsy is performed, the tests yield different results. But when the blood and sample are collected concurrently, or when the alterations are so-called truncal driver mutations that are likely to be present before and after treatment, concordance for important oncogenes approaches 85% or higher4,5.

For instance, researchers at the University of Pennsylvania Perelman School of Medicine looked at 50 advanced lung cancer patients for which Guardant360 and tissue sequencing results were available. They found that when the tests were performed within two weeks of each other, concordance for the important EGFR oncogene was 100 percent, but when the blood was tested more than 6 months after tissue testing concordance fell to 60%. The authors concluded that the blood test is a real-time test that can capture newly evolved tumor mutations not present in older tissue biopsies6.

In another example, researchers from the University of California, Davis showed that the somatic genomic landscape detected by Guardant360 in more than 15,000 patients was highly similar to the landscape described in other population-scale studies7, including The Cancer Genome Atlas (TCGA). The exception to this was with resistance alterations, which were largely absent from the treatment naïve TCGA population, but were often found in the Guardant patient cohort of advanced patients.

Tissue acquired at the time of a patient’s diagnosis is often outdated and many times can’t help a doctor determine if their patient is a candidate for a new drug. And a repeat invasive biopsy may be expensive, painful, and dangerous, which is why many doctors order liquid biopsies at progression.8

Temporal heterogeneity can also have important implications for medical testing even in the absence of tumor evolution. For example, anti-cancer treatments including chemotherapy, radiotherapy, and targeted therapies kill cancer cells, which can decrease the amount of tumor in liquid and tissue biopsies alike. Indeed, just as aspirin may temporarily reduce your fever when you have the flu, producing “discordant” results on your thermometer if you take your temperature before and during treatment, liquid and/or tissue biopsies taken after or during cancer therapy may detect fewer variants than tests performed prior to therapy because fewer cancer cells remain.

Heterogeneity and the future of cancer care
Cancer is a complex disease. A single patient’s cancer can harbor dozens of different genomic alterations spread unevenly throughout their body, and these alterations can evolve in response to treatment. As we increase our collective understanding of tumor biology, patients will benefit from more accurate diagnostics that can follow this evolution and guide dynamic precision treatment plans that evolve as the tumor does throughout the course of a patient’s care.

VIENNA, Dec. 5, 2016 – Guardant Health reported the results of the largest ever genomic study of advanced non-small cell lung cancer (NSCLC) patient cell-free circulating tumor DNA (ctDNA) at the 17th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (IASLC).

“It is clear from this retrospective data set that comprehensive genomic profiling performed in shed tumor DNA isolated from patient plasma can provide reliable, actionable information that can be used to guide treatment decision-making in metastatic lung cancer” said Philip Mack, PhD, UC Davis Director of Molecular Pharmacology, who presented the study.

The study looked at the genomic landscape reported by Guardant360 across more than 8,000 advanced NSCLC patients. It demonstrated that mutations in genes that frequently drive NSCLC, such as EGFR, KRAS, ALK, and ROS1, were detected by Guardant360 at very similar frequencies to the alterations found in The Cancer Genome Atlas, a public database of cancer genomics drawn from tissue samples from patients who had not yet been treated or had early-stage cancer. These data indicate that Guardant360 provides an accurate snapshot of the genomic landscape of the tumor. In contrast, the mutations that develop in response to treatment and often lead to resistance were rarely seen in the largely treatment-naïve TCGA population, but were detected by Guardant360 at rates consistent with the published literature.

The study also demonstrated the high accuracy of Guardant360 mutation identification. In a sub analysis of 229 samples for which matched tissue sequencing results were available, when Guardant360 identified an actionable alteration it was confirmed in tissue genotyping 92% to 100% of the time. Additionally, Guardant360 identified previously undetected actionable alterations in 28% of patients who had undergone uninformative invasive biopsy-based genomic testing.

“Molecular testing in lung cancer is in rapid transition from tissue testing to plasma cell-free DNA,” said Dr. David Gandara, director of the Thoracic Oncology Program at the UC Davis Comprehensive Cancer Center. “These are exciting findings for any oncologist seeing patients with advanced lung cancer. They not only show that Guardant360 finds what doctors would expect to find, but that the test frequently detects these critical alterations in patients when earlier tissue testing fell short.”

A comprehensive, highly sensitive liquid biopsy may be the best way to assess the genomic status of advanced NSCLC patients at progression. With the average cost of a lung biopsy exceeding $14,600, and industry guidelines calling for doctors to perform comprehensive genomic testing at progression, these results suggest there is great value in reliably acquiring genomic information through a simple blood draw.

“Almost one third of advanced NSCLC patients do not undergo basic EGFR and ALK testing, and 85% do not get the broad molecular profiling called for in national guidelines. Now we can help patients get access to the much better outcomes associated with targeted therapies without the risk from a repeat invasive tissue biopsy,” said Dr. Richard Lanman, Chief Medical Officer of Guardant Health and a co-author of the study. “Indeed, the guidelines now recognize that plasma testing should be considered when tissue is unavailable”

Guardant360 the most validated comprehensive liquid biopsy, and was the first to be introduced in 2014. It has since been used by more than 3,000 oncologists to identify somatic genomic alterations associated with targeted therapies in the ctDNA of more than 30,000 patients with advanced cancer.

“These results affirm what thousands of Guardant360 customers already know,” said Helmy Eltoukhy, CEO of Guardant Health. “Guardant360 is a comprehensive, accurate, and sensitive test that helps patients and doctors reach the best treatment decisions with minimal risk and has the potential to replace repeat tissue biopsies as the gold standard in lung cancer.”

About Guardant Health
Guardant Health is focused on conquering cancer with breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $200 million from leading venture capital firms. Its first product, Guardant360, came to market in 2014, and is now the most validated and sensitive comprehensive liquid biopsy commercially available.

Guardant360, the gold standard in comprehensive liquid biopsy, helps oncologists maximize targeted treatment options for their advanced cancer patients. Ever since we pioneered the field of comprehensive liquid biopsy in 2014, we have continued to innovate with a singular focus on transforming cancer care.

Blood-based cancer DNA testing is our main focus. It’s what we do best. It’s why the technology has continued to improve so rapidly since we introduced Guardant360. Today we are pleased to announce significant performance improvements to Guardant360. We have improved its industry-leading performance while adding more druggable targets to the panel. Additionally, we’re introducing a simplified Guardant360 report, more online physician decision-support tools, and patient-access resources.

Guardant360 identifies somatic genomic alterations in circulating tumor DNA that are sensitizing or resistant to targeted therapies. The test has been used by more than 3,000 oncologists to help nearly 30,000 advanced cancer patients. Everything we’ve learned about tumor biology and bioinformatics from working at this scale has helped us further optimize Guardant360 for increased clinical sensitivity and utility.

Put simply: our technology gets better with every test we run. And even to our own surprise, the pace of technology improvement has been getting steeper as the amount of data we collect grows. But this actually makes perfect sense — issues that occur only every one or two thousand samples can only be solved by processing tens of thousands of blood samples a year.

A New, More Sensitive 73-Gene Panel

Among comprehensive liquid biopsies, the new 73-gene Guardant360 panel covers the most sensitizing and resistance markers for targeted therapies. How does this affect patients? The increased coverage will give physicians more opportunities to direct patient care with BRAF/MEK inhibitors, NTRK3 inhibitors, PARP inhibitors, tyrosine kinase inhibitors, MET inhibitors, and more. Additionally, bioinformatics and biochemistry innovations now allow us to confidently call alterations down to allele frequencies of 0.02% in some cases. That’s important because more than half of the alterations Guardant360 has ever reported were detected at an allele frequency of less than 0.4%.

Streamlined Reporting

We know physicians are busy and we are always looking for ways to save them time. We are excited to introduce an updated Guardant360 report designed to reduce the effort spent interpreting results. The new report helps clinicians more quickly identify important drug targets and known resistance alterations detected by Guardant360. We’ve also added new features designed to make it easier to identify and enroll patients into nearby clinical trials.

iPhone App for Reports on the Go

This enhanced Guardant360 experience also includes an improved, HIPAA-compliant, iPhone application that physicians can use to easily access and explore their patients’ reports on-the-go. They can also securely share Guardant360 reports with colleagues, view historical trends in druggable alterations from prior reports, and access support services from our team of medical science liaisons.

myGuardant Patient Portal

The new Guardant360 also provides an enhanced experience for patients. Through the myGuardant patient portal, patients can track sample progress and view their reports upon release by their physician, access financial assistance programs, and find educational resources.

We know our work is not complete, and we will continue to improve our products. Every test we run helps make Guardant360 better. We thank every patient and oncologist who have made us part of their practice and care. These improvements, and future improvements to Guardant360, are only possible by all the stakeholders working together.

Want to learn more?

If you would like to learn more about the enhanced Guardant360, or schedule a consultation with a member of our Medical Affairs team, please contact your local Account Executive

In his final State of the Union, President Obama announced the Cancer Moonshot, an ambitious national effort to accelerate cancer research. Critics said it was mission impossible.

At Guardant Health, we believe that no single entity can deliver on the goals of the Cancer Moonshot, and it will take a coordinated effort to bend cancer mortality curves. Our contribution, data associated with Guardant360, the industry’s gold-standard non-invasive genomic cancer test, is a key enabling tool that will reach its full potential only when combined with improved methods for sharing and analyzing clinical data, drug discovery and validation engines, advances in basic science, and coordinated governmental processes for drug approvals.

Today’s launch of the Blood Profiling Atlas, an open database of blood-based cancer genomic profiles and analytical methods, is proof that the Moonshot can make rapid progress. A diverse group of diagnostic, pharmaceutical, and digital health companies representing the entire cancer “stack,” along with academic researchers are contributing their data and expertise. Guardant Health is proud and excited to be a part of the effort, and as the pioneers in liquid biopsy, we believe we can help conquer cancer with data. The value of liquid biopsies lies not only in their role as a critical tool for cancer management, but in the data they reveal and the ease and frequency with which these data can be obtained.

Having sequenced nearly 30,000 patients with our clinical test, Guardant360, we know that liquid biopsies are already a critical and often life-changing non-invasive alternative to match advanced cancer patients with targeted therapies.

As a result, Guardant360 is quickly being incorporated into the standard of care in many major cancer centers across the United States. Indeed, over 30% of lung cancer patients are not genotyped in accordance with basic recommendations from national guidelines committees, and almost 85% are not genotyped with respect to their more advanced suggestions. A fundamental reason for this extraordinary gap is the difficulty of accessing lung tumor biopsy tissue given the procedure’s $14,000 cost, 19% complication rate, and >1% mortality rate.

Thus, accessing tumor DNA in cancer patients using direct tissue biopsies often comes with great risk and expense, creating an “inertial barrier” for obtaining genomic data. At Guardant Health, we have worked to reduce this barrier via Guardant360, as we believe this will lead to dramatic non-linear improvements in our collective understanding, and therefore approaches, to treating cancer. For example, our profiling of thousands of patients who have undergone one or more lines of therapy is already shedding light on how cancer responds to treatment. We are reminded by numerous specific patient examples in which tissue profiling missed information necessary to select the next therapy, often due to the heterogeneous nature of the disease. In these cases, blood-based profiling was able to pick up acquired resistance mutations that were the key for unlocking the next appropriate therapy. The Blood Profiling Atlas is an important affirmation of our approach to decoding cancer evolution, and a reminder that we are just scratching the surface.

Furthermore, reducing inertial barriers not only increases efficiency and our pace of learning, it creates new applications. The move from tissue to blood in oncology echoes the change from wired to wireless communications. Wireless turned out to be far more than just a substitute for when wired connections were unavailable. It was a catalyst for world-changing applications that required wireless connectivity like Uber, Waze, WhatsApp, FaceTime, and many more.
Similarly, the breakthrough of liquid biopsies is not simply the ability to profile cancer patients’ tumors, but the promise that they can capture the whole-body summary of an individual’s cellular activity. Indeed, they open up a new way of precisely measuring molecular changes across disease states and in response to treatments at a vastly accelerated pace.

And like the breakthrough of wireless and subsequent deluge of inventions, we think this new platform will be the integral accelerant for enabling numerous essential health applications. These will likely include advances in early detection and disease monitoring, as well as many others yet to be imagined.

We are hopeful that the commitment we and other companies are making to the Blood Profiling Atlas will accelerate the adoption of this technology, spur advances in oncology, and unlock new applications to benefit clinicians and patients.

Redwood City, Calif. and Dubai – September 19, 2016 – Guardant360®, the leading comprehensive liquid biopsy, will be available to more oncologists and their cancer patients in the Middle East through a distribution agreement between Guardant Health and IPS Genomix, the companies announced.

“We believe the great promise of Guardant360 is its ability to democratize access to critical information about a patient’s cancer,” said Helmy Eltoukhy, Guardant Health’s co-founder and CEO. “Now, through a single blood draw, oncologists across the United Arab Emirates, Saudi Arabia, Qatar, Kuwait, Oman, Lebanon, Egypt and Jordan will have access to the same comprehensive information about the genomics of their patients’ solid tumors as doctors at the leading U.S. cancer centers.”

Guardant360 is the first and most validated comprehensive liquid biopsy available commercially. It provides comprehensive analysis of all major classes of somatic tumor alterations. The test interrogates 70 cancer genes from a simple blood draw, with near-perfect specificity and high sensitivity. Using Guardant Health’s proprietary Digital Sequencing technology, Guardant360 can detect cell-free DNA at mutant allele fractions (MAF) as low as 0.1%, and will help match patients to targeted therapies and access precision care through a simple blood test.

IPS Genomix will handle distribution, reimbursement, and will facilitate patient access for Guardant360 in The United Arab Emirates, Saudi Arabia, Qatar, Kuwait, Oman, Lebanon, Egypt and Jordan. Guardant Health will perform all testing at its CLIA-certified and CAP-accredited laboratory in Redwood City, Calif.

“With more than 25 years of experience bringing world-class medical products to doctors in the Middle East and Africa, we aim to provide patients with the most effective and appropriate tools in fighting cancer.” said Ahmed Yacout, Chairman and CEO of IPS Group. “We are excited to help Guardant Health in this region through our dedicated personalized medicine expert teams in the region and expect oncologists here will rapidly adopt this exciting new technology.”

About Guardant Health
Guardant Health, headquartered in Redwood City, Calif., is focused on developing breakthrough diagnostics that can transform cancer from a silent killer into a manageable disease. Guardant Health was founded in 2012 by a team of serial entrepreneurs with expertise in next-generation sequencing, single-cell genomics, and cancer diagnostics. The company has raised $200 million from leading venture capital firms and its first product, Guardant360, came to market in 2014. The team is committed to positively and significantly impacting patient health through technology that addresses long-standing unmet needs in oncology.

About IPS Genomix
IPS Genomix was founded in 2013 by a group of experts who have been in the healthcare domain for more than 25 years in the Middle East and Africa territory. IPS Genomix partners with US and European molecular diagnostic companies, to provide a diversification of genomic testing services focused on improving patient care utilizing the latest technologies of prognostic, predictive & personalized medicine. The treating physician can then individualize the treatment of his patients to enhance the prevention and/or treatment of certain conditions and diseases. Given the rapid evolution of this particular field, IPS Genomix constantly incorporates new technology platforms and assays to offer physicians and their patients with the most up to date, reliable and cutting edge personalized medicine tools.

REDWOOD CITY, Calif., June 27, 2016 – Guardant Health, the leader in comprehensive liquid biopsy, announced a distribution and marketing partnership with Oncotest-Teva, [a subsidiary of Teva Pharmaceutical Industries Ltd. in Israel]. The partnership will make Guardant360®, Guardant Health’s groundbreaking, non-invasive genomic sequencing test for patients with advanced cancer, widely available to oncologists and patients in Israel.

Guardant360 is the first commercially available comprehensive liquid biopsy. It detects and analyzes DNA fragments from solid tumors that circulate in the blood of patients with advanced cancers. Used in the United States by leading oncologist at top cancer centers, the test requires just a simple blood draw to detect all four major classes of somatic genomic alterations that cause solid tumors to grow and spread, and can help doctors select an appropriate targeted therapy.

Oncotest-Teva will market Guardant360 and handle local sample logistics and patient reimbursement in Israel. Guardant Health will perform all testing at its CLIA-certified, CAP-accredited facilities in Redwood City, Calif.

“We’re excited to have Oncotest-Teva as a partner, and we look forward to seeing our test and technology help more patients,” said Helmy Eltoukhy, Guardant Health’s co-founder and CEO. “Patients fighting advanced cancer should not have to subject themselves to potentially risky biopsy procedures to get the best information about their cancer.”

“Again and again we are impressed by the sensitivity and high accuracy of this technology to quickly and easily trap rare mutations in a patient’s blood,” said Nir Peled, MD PhD, Head of the Thoracic Cancer Unit at Davidoff Cancer Center, Rabin Medical Center, Israel. “There is no question that this technology transforms oncology practice today. It should be noted that this test is currently not included in the Israeli healthcare basket.”

“This is one of the biggest breakthroughs in the field of cancer genomics,” said Prof. Tamar Peretz, MD PhD, Head of the Sharett Institute of Oncology, Hadassah Medical Center, Jerusalem. “It allows us to pinpoint mutations in cancer without the need for biopsy. Now we can tackle the biggest obstacle in cancer treatment: progression and sustainability. Monitoring of treatment and early detection of acquired resistance will allow us to handle the complete range of cloning heterogeneity of the disease more accurately, quickly, and without a biopsy.”

“For nearly two decades Oncotest-Teva has been the pioneer and leader of personalized Oncology in Israel, actively engaged in bringing the most reliable innovative technologies to patients and physicians,” said Dr. Lior Soussan-Gutman, founder and managing director of Oncotest-Teva, Tel Aviv. “We are excited to provide Guardant360 in Israel, with its breakthrough liquid-biopsy sequencing technology that changes the treatment paradigm for cancer patients. We can now offer patients analysis of their tumor DNA quickly, and confront temporal and spatial limitations of tissue-based biopsies. We are proud to continue to lead personalized medicine in Israel.”

About Guardant360
Guardant360 is the first CLIA-certified, CAP-accredited comprehensive next generation sequencing-based liquid biopsy. The 70-gene blood test is used in advanced cancer patients with visceral solid tumor cancers or metastases, and interrogates all four types of genomic alterations. The test is used to prevent repeat invasive biopsies when cancer has progressed or recurred despite treatment, or when an initial biopsy is unobtainable or has insufficient tissue. It is the only ctDNA test that includes all guideline-recommended somatic genomic targets in a single test. Unlike hotspot tests, Guardant360 sequences each covered exon completely to avoid missing rare mutations. Based on the tumor genomic profile, clinicians receive a report of actionable genomic alterations and a list of FDA-approved treatments and clinical trials for which the patient could be eligible. Guardant360 has undergone extensive analytical and clinical validation and is supported by publications with leading cancer centers globally.

About Guardant Health
Guardant Health is focused on developing breakthrough diagnostic technologies that can transform cancer from a silent killer into a manageable disease. Guardant Health was founded in 2012 by a team of serial entrepreneurs with expertise in next-generation sequencing, single-cell genomics and cancer diagnostics. The team is committed to improving patient health through technology that addresses long-standing unmet needs in oncology.

About Oncotest-Teva
Oncotest-Teva is a pioneer in the field of personalized medicine in Israel. For almost two decades, Oncotest-Teva has been focusing on identification of novel approaches to diagnosing malignant diseases and predicting the course of disease, according to the unique genetic profile of the patient and tumor cells, and more precise and more effective matching of therapeutic directions.

“Guardant360 has already helped thousands of patients avoid the costs, complications and delays of invasive biopsy procedures,” said Helmy Eltoukhy, Guardant Health CEO. “Pangaea and MedSIR have strong track records in clinical trial design and execution in Spain and are ideal partners for Guardant Health.”

Guardant Health will provide its Guardant360 liquid biopsy test, while MedSIR will serve as the sponsor in Spain and Pangaea as the central lab. The Dr. Rosell Oncology Institute, with a strong presence in hospitals from the Quirónsalud group, is one of the primary centers driving patient recruitment.

“Comprehensive liquid biopsy technology like Guardant Health’s that can achieve both high sensitivity and high specificity has the potential to help us identify all of the growing list of mutations that can be targeted with matched therapy,” said Dr. Rafael Rosell, Director of the Cancer Biology and Precision Medicine Program at the Catalan Institute of Oncology in Barcelona, as well as co-founder of Pangaea Biotech and IOR. “Guardant Health’s commitment to rigorously study this technology will support its broad adoption by oncologists.”

“This agreement with Guardant Health is the start of a long-lasting partnership with one of the most important global players in next-generation sequencing of liquid biopsy” said Javier Rivela, Pangaea Biotech CEO. “We believe that by joining forces with MedSIR, a unique clinical trial design and management company and a strategic partner for us, we have a solid team to take on this innovative project.”

About Guardant Health
Guardant Health, headquartered in Redwood City, Calif., is focused on developing breakthrough diagnostics that can transform cancer from a silent killer into a manageable disease. Guardant Health was founded in 2012 by a team of serial entrepreneurs with expertise in next-generation sequencing, single-cell genomics, and cancer diagnostics. The team is committed to positively and significantly impacting patient health through technology that addresses long-standing unmet needs in oncology.

About Pangaea Biotech
Pangaea Biotech S.L is a biotechnology company led by world-renowned oncologist Dr Rafael Rosell. Founded in 2007, Pangaea has grown rapidly to become a reference laboratory in its field and has established client relationships with some of the largest global pharmaceutical, diagnostics and biotech companies. Pangaea has three main areas of activity: development of diagnostic tools and services – with a special focus on Liquid Biopsy – development of new anti-cancer drugs, and patient care provided by the Dr Rosell Oncology Institute (IOR) located in Quirón Dexeus University Hospital, Barcelona, Sagrat Cor University Hospital, Barcelona, and University Hospital General de Cataluyna, Sant Cugat dels Valles. Both Pangaea and IOR are highly experienced in the field of clinical trials and offer a dedicated Clinical Trials Unit and comprehensive molecular diagnostics and pathology testing services.

About MedSIR
Medica Scientia Innovation Research, MedSIR, is an Academic Research Organization founded in 2012 whose core activity is the design and management of investigator-initiated clinical studies. Through its international network of clinical experts, MedSIR seeks to identify the most innovative, strategic, and clinically relevant ideas for clinical trials that will benefit patients, add to scientific knowledge, and boost product development. Based in Barcelona, MedSIR applies an international focus to all of its activities, be it the identification of strategic ideas or securing the participation of top international centers in its clinical studies. Since it was founded, MedSIR has successfully launched and managed clinical studies in tumors such as breast, lung and endometrial, with a focus on the early strategic phases of clinical development.

REDWOOD CITY, Calif., April 22, 2016 – Guardant Health® announced that oncologists at San Antonio Military Medical Center, one of the U.S. military’s premier medical facilities, can now order the breakthrough liquid biopsy Guardant360 to help guide therapy selection for patients fighting advanced cancers, and to avoid further invasive biopsies.

“We’re honored our technology can now help these patients,” said Helmy Eltoukhy, CEO of Guardant Health. “We’re committed to making Guardant360 available to anyone who needs it. We are thrilled it is now available to oncologists at one of the world’s top military hospitals.”

Guardant360 provides comprehensive genomic analysis of all major classes of somatic tumor alterations from a simple blood draw. Guardant Health’s unique digital sequencing method allows for near-perfect specificity and high sensitivity, and since 2014, more than 2,000 oncologists have used Guardant360 to test 20,000 patient samples. The test analyzes fragments of solid-tumor DNA found in the blood of advanced cancer patients.

About Guardant360
Guardant360 is the first CLIA-certified, CAP-accredited comprehensive next generation sequencing-based liquid biopsy test indicated for cancer genomics. The 70-gene blood test is used in advanced cancer patients with visceral solid tumor cancers or metastases, and interrogates all four types of genomic alterations. The test is used to prevent repeat invasive biopsies when cancer has progressed or recurred despite treatment, or when an initial biopsy is unobtainable or has insufficient tissue. It is the only ctDNA test that includes all guideline-recommended somatic genomic targets in a single test. Unlike hotspot tests, Guardant360 sequences each covered exon completely so as not to avoid missing rare mutations. Based on the tumor genomic profile, clinicians receive a report of actionable genomic alterations and a list of FDA-approved treatments and clinical trials for which the patient could be eligible. Guardant360 has undergone extensive analytical and clinical validation and is supported by publications with leading global cancer centers globally.

About Guardant Health
Guardant Health, headquartered in Redwood City, Calif., is focused on developing breakthrough diagnostics that can transform cancer from a silent killer into a manageable disease. Guardant Health was founded in 2012 by a team of serial entrepreneurs with expertise in next-generation sequencing, single-cell genomics, and cancer diagnostics. The company has raised $200 million from leading venture capital firms and its first product, Guardant360, came to market in 2014. The team is committed to positively and significantly impacting patient health through technology that addresses long-standing unmet needs in oncology.